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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K133126
Device Name K7 LUMBAR SPACERS
Applicant
K7, LLC
P.O. Box 566
Chesterland,  OH  44026
Applicant Contact KAREN E WARDEN, PHD
Correspondent
K7, LLC
P.O. Box 566
Chesterland,  OH  44026
Correspondent Contact KAREN E WARDEN, PHD
Regulation Number888.3080
Classification Product Code
MAX  
Date Received09/30/2013
Decision Date 12/09/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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